Dexmedetomidine in Topical Versus Peribulbar Anesthesia for Cataract Surgery

NCT ID: NCT05692167

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-15
• Study Completion Date: 2023-10-15

Brief Summary

The aim of this study is to compare efficacy of dexmedetomidine as an additive to topical versus peribulbar anesthesia for cataract surgery

Detailed Description

Ocular surgery may be performed under topical, regional, or general anesthesia. The first recorded use of regional anesthesia for surgery was the instillation of cocaine into the conjunctival sac in 1884 by an Austrian ophthalmologist.

Davis and Mandel in 1986 described the peribulbar block, peribulbar block has delayed onset and need a higher volume of local anesthetic (LA) than a retrobulbar block. But the peribulbar block is away from intra-conal space and so produce fewer complication.

Dexmedetomidine is used as adjuvant to LA drugs in peripheral nerve block, brachial plexus block and intrathecal anesthesia with satisfactory results. A more recent study using dexmedetomidine (50 μg) with the peribulbar block before cataract surgery demonstrated an IOP decrease similar to IV dexmedetomidine administration and greater than a peribulbar block without dexmedetomidine.

Conditions

Dexmedetomidine; Cataract Surgery; Peribulbar; Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Topical dexmedetomidine group

Patients will receive mixture of one milliliter of dexmedetomidine-HCl and local anesthetic

Group Type: ACTIVE_COMPARATOR

Topical dexmedetomidine

Intervention Type: DRUG

Patients will receive mixture of one milliliter of dexmedetomidine-HCl and local anesthetic

Reginal dexmedetomidine group

Patients will receive mixture of bupivacaine 0.5% (4.5 ml) + lidocaine 2% (4.5 ml) + dexmedetomidine 50 μg (1 ml) in peribulbar block

Group Type: ACTIVE_COMPARATOR

Reginal dexmedetomidine

Intervention Type: DRUG

Patients will receive mixture of bupivacaine 0.5% (4.5 ml) + lidocaine 2% (4.5 ml) + dexmedetomidine 50 μg (1 ml) in peribulbar block

Interventions

Topical dexmedetomidine

Patients will receive mixture of one milliliter of dexmedetomidine-HCl and local anesthetic

Intervention Type: DRUG

Reginal dexmedetomidine

Patients will receive mixture of bupivacaine 0.5% (4.5 ml) + lidocaine 2% (4.5 ml) + dexmedetomidine 50 μg (1 ml) in peribulbar block

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• American Society of Anesthesiologists (ASA) physical status classification I or II who scheduled for eye surgery

Exclusion Criteria

• Patients who are younger than 18 years
• The usual contraindications for regional anesthesia such as patients refusing LA
• Clotting abnormalities
• Impaired mental status
• Allergy to any of the study medications
• patients had the severe cardiac disease
• chronic obstructive lung disease and a history of sleep apnea
• contraindications to the use of dexmedetomidine
• history or significant cardiovascular disease risk factors
• significant coronary artery disease or any known genetic predisposition
• history of any kind of drug allergy
• drug abuse
• psychological or other emotional problems
• special diet or lifestyle
• clinically significant abnormal findings in physical examination
• electrocardiographic (ECG) or laboratory screening
• known systemic disease requiring the use of anticoagulants.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Fouad Algyar

Lecturer of Anaesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammed F Algyar, MD

Role: PRINCIPAL_INVESTIGATOR

Lecturer of Anaesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University

Locations

Mohammed Fouad Mohamed Algyar

Kafr ash Shaykh, Kafrelsheikh, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohammed F Algyar, MD

Role: CONTACT

mohammad.algaiar@med.kfs.edu.eg

00201111645345 ext. 047

Facility Contacts

Mohammed F Algyar, MD

Role: primary

mohammad.algaiar@med.kfs.edu.eg

00201111645345 ext. 047

Other Identifiers

MKSU 50-11-3

Identifier Type: -

Identifier Source: org_study_id